ASTM E2810-11e1
(Practice)Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units
SIGNIFICANCE AND USE
4.1 The methodology was originally developed (1-4)6 for use in drug content uniformity and dissolution but has general application to any multistage test with multiple acceptance criteria. Practice E2709 summarizes the statistical aspects of this methodology. This practice applies the general methodology of Practice E2709 specifically to the UDU test.
4.1.1 While other methods can be used to estimate the probability of passing the UDU test, they are outside the scope of this practice.
4.2 The UDU test procedure describes a two-stage sampling test, where at each stage one can pass or continue testing, and the decision to fail is deferred until the second stage. At each stage there are acceptance criteria on the test results as outlined in Table 1. Note 1—All measurements of dosage units and criteria values are in percentage label claim (%LC). At each stage calculate the sample average, X, and the sample standard deviation, s.
4.3 The UDU test is a market standard. The USP General Notices include the following statement about compendial standards. “The similarity to statistical procedures may seem to suggest an intent to make inference to some larger group of units, but in all cases, statements about whether the compendial standard is met apply only to the units tested.” Therefore, the UDU procedure is not intended for inspecting uniformity of finished product for lot/batch release or as a lot inspection procedure.
4.3.1 The UDU test defines a product requirement to be met at release and throughout the shelf-life of the product.
4.3.2 Passing the UDU test once does not provide statistical assurance that a batch of drug product meets specified statistical quality control criteria.
4.4 This practice provides a practical specification that may be applied when uniformity of dosage units is required. An acceptance region for the mean and standard deviation of a set of test results from the lot is defined such that, at a prescribed confidence level, the...
SCOPE
1.1 This practice provides a general procedure for evaluating the capability to comply with the Uniformity of Dosage Units (UDU) test. This test is given in General Chapter Uniformity of Dosage Units of the USP, in 2.9.40 Uniformity of Dosage Units of the Ph. Eur., and in 6.02 Uniformity of Dosage Units of the JP, and these versions are virtually interchangeable. For this multiple-stage test, the procedure computes a lower bound on the probability of passing the UDU test, based on statistical estimates made at a prescribed confidence level from a sample of dosage units.
1.2 This methodology can be used to generate an acceptance limit table, which defines a set of sample means and standard deviations that assures passing the UDU test for a prescribed lower probability bound, confidence level, and sample size.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: E2810 − 11
StandardPractice for
Demonstrating Capability to Comply with the Test for
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Uniformity of Dosage Units
This standard is issued under the fixed designation E2810; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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ε NOTE—Editorial corrections made throughout in February 2013.
1. Scope 2.2 Other Documents:
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JP Japanese Pharmacopoeia
1.1 This practice provides a general procedure for evaluat-
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Ph. Eur. European Pharmacopoeia
ing the capability to comply with the Uniformity of Dosage
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USP United States Pharmacopeia
Units (UDU) test. This test is given in General Chapter <905>
Uniformity of Dosage Units of the USP, in 2.9.40 Uniformity
3. Terminology
of Dosage Units of the Ph. Eur., and in 6.02 Uniformity of
3.1 Definitions—See Terminology E2363 for a more exten-
Dosage Units of the JP, and these versions are virtually
sive listing of terms in ASTM Committee E55 standards.
interchangeable. For this multiple-stage test, the procedure
computesalowerboundontheprobabilityofpassingtheUDU
3.2 Definitions of Terms Specific to This Standard:
test, based on statistical estimates made at a prescribed
3.2.1 acceptable parameter region, n—the set of values of
confidence level from a sample of dosage units.
parameters characterizing the distribution of test results for
which the probability of passing the lot acceptance procedure
1.2 Thismethodologycanbeusedtogenerateanacceptance
is greater than a prescribed lower bound.
limit table, which defines a set of sample means and standard
deviations that assures passing the UDU test for a prescribed
3.2.2 acceptance limit, n—the boundary of the acceptance
lower probability bound, confidence level, and sample size.
region, for example, the maximum sample standard deviation
for a given sample mean.
1.3 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the 3.2.2.1 Discussion—The coefficient of variation (relative
standard deviation) may be substituted for the standard devia-
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica- tion where applicable.
bility of regulatory limitations prior to use.
3.2.3 acceptance region, n—the set of values of parameter
estimates (that is, sample mean and standard deviation) where
2. Referenced Documents
confidence limits attain a prescribed lower bound on the
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2.1 ASTM Standards:
probability of passing a lot acceptance procedure.
E2363 Terminology Relating to ProcessAnalytical Technol-
3.2.4 confidence level, C, n—the prescribed overall level for
ogy in the Pharmaceutical Industry
calculating the uncertainty region of the parameters from the
E2709 Practice for Demonstrating Capability to Comply
sample estimates.
with an Acceptance Procedure
3.2.4.1 Discussion—The preset confidence level is stated as
a percentage, for example, 100 (1 –α) = 95 %, where α is a
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This practice is under the jurisdiction of ASTM Committee E55 on Manufac- risk that is allocated to the two parameters being estimated.
ture of Pharmaceutical Products and is the direct responsibility of Subcommittee
E55.03 on General Pharmaceutical Standards.
Current edition approved Oct. 1, 2011. Published December 2011. DOI:
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10.1520/E2810-11. Available from the Pharmaceuticals and Medical Devices Agency, Japan,
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or http://jpdb.nihs.go.jp.
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contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM AvailablefromtheEuropeanCouncil,Strasbourg,France,http://www.edqm.eu.
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Standards volume information, refer to the standard’s Document Summary page on Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville,
the ASTM website. MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E2810 − 11
3.2.5 lower probability bound, LB, n—thenominalprobabil- application to any multistage test with multiple acceptance
ity of passing the UDU test for a given set of parameter criteria. Practice E2709 summarizes the statistical aspects of
estimates. this methodology. This practice applies the general methodol-
ogy of Practice E2709 specifically to the UDU test.
3.2.6 multiple-stage acceptance procedure, n—a procedure
4.1.1 While other methods can be used to estimate the
that involves more than one stage of sampling and testing a
probability of passing the UDU test, they are outside the scope
given
...
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